The Effect of Different Types of Music on Pain and Anxiety During Wound Care Procedures in Patients With Venous Ulcers

NCT ID: NCT07287254

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2024-09-20

Brief Summary

Objective: To evaluate the effects of different types of music (instrumental Turkish music and Western music without lyrics) played during wound care on pain, anxiety, and patient satisfaction among individuals with venous ulcers.

Methods: In this randomized controlled trial, 97 patients with venous ulcers were assigned to three groups: Western Music (n=32), Turkish Music (n=32), and Control (n=33). Patients in the music groups listened to their assigned music during routine wound dressing, while all patients received individualized, evidence-based care. Pain and anxiety were measured with VAS and STAI before, during, and after dressing, and patient satisfaction was assessed with VAS post-procedure.

Conditions

Venous Leg Ulcer; Pain; Anxiety

Keywords

Music Therapy; Pain; Anxiety; Venous Leg Ulcer; Wound Dressing; Nursing Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Turkish music

Music Intervention

Group Type: EXPERIMENTAL

Turkish Music Intervention

Intervention Type: OTHER

The music intervention was prepared by a music therapy specialist. Patients in the intervention groups listened only to the music portion of the therapy via a USB player. The music was played continuously and repeatedly in the outpatient clinic for approximately 30-60 minutes (for patients whose dressing lasted at least 30-45 minutes) at a moderate volume of 20-45 dB (sufficient to avoid interfering with speech or communication). To enhance the effectiveness of music therapy, the listening experience was structured with gradual variations in tempo and dynamics. Major tonal sequences were preferred to stimulate neural activity. The selected pieces included instrumental Western Classical music and Turkish music (Nihavend makam), starting at a tempo of 60 bpm (Adagio) and gradually increasing to 100 bpm (Andante). Examples include W.A. Mozart's Flute and Horn Concertos for Western Classical music, and instrumental compositions in the Nihavend makam for Turkish music.

Western music

Music Intervention

Group Type: EXPERIMENTAL

Western Music Intervention

Intervention Type: OTHER

The music intervention was prepared by a music therapy specialist. Patients in the intervention groups listened only to the music portion of the therapy via a USB player. The music was played continuously and repeatedly in the outpatient clinic for approximately 30-60 minutes (for patients whose dressing lasted at least 30-45 minutes) at a moderate volume of 20-45 dB (sufficient to avoid interfering with speech or communication).\[22\] To enhance the effectiveness of music therapy, the listening experience was structured with gradual variations in tempo and dynamics. Major tonal sequences were preferred to stimulate neural activity. The selected pieces included instrumental Western Classical music and Turkish music (Nihavend makam), starting at a tempo of 60 bpm (Adagio) and gradually increasing to 100 bpm (Andante). Examples include W.A. Mozart's Flute and Horn Concertos for Western Classical music, and instrumental compositions in the Nihavend makam for Turkish music.

control group

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Turkish Music Intervention

The music intervention was prepared by a music therapy specialist. Patients in the intervention groups listened only to the music portion of the therapy via a USB player. The music was played continuously and repeatedly in the outpatient clinic for approximately 30-60 minutes (for patients whose dressing lasted at least 30-45 minutes) at a moderate volume of 20-45 dB (sufficient to avoid interfering with speech or communication). To enhance the effectiveness of music therapy, the listening experience was structured with gradual variations in tempo and dynamics. Major tonal sequences were preferred to stimulate neural activity. The selected pieces included instrumental Western Classical music and Turkish music (Nihavend makam), starting at a tempo of 60 bpm (Adagio) and gradually increasing to 100 bpm (Andante). Examples include W.A. Mozart's Flute and Horn Concertos for Western Classical music, and instrumental compositions in the Nihavend makam for Turkish music.

Intervention Type: OTHER

Western Music Intervention

The music intervention was prepared by a music therapy specialist. Patients in the intervention groups listened only to the music portion of the therapy via a USB player. The music was played continuously and repeatedly in the outpatient clinic for approximately 30-60 minutes (for patients whose dressing lasted at least 30-45 minutes) at a moderate volume of 20-45 dB (sufficient to avoid interfering with speech or communication).\[22\] To enhance the effectiveness of music therapy, the listening experience was structured with gradual variations in tempo and dynamics. Major tonal sequences were preferred to stimulate neural activity. The selected pieces included instrumental Western Classical music and Turkish music (Nihavend makam), starting at a tempo of 60 bpm (Adagio) and gradually increasing to 100 bpm (Andante). Examples include W.A. Mozart's Flute and Horn Concertos for Western Classical music, and instrumental compositions in the Nihavend makam for Turkish music.

Intervention Type: OTHER

Other Intervention Names

music therapy; Music therapy

Eligibility Criteria

Inclusion Criteria

• Patients attending the outpatient clinic with venous leg ulcers (CEAP classification: C6 - active ulcers)
• Age between 18 and 65 years
• Absence of neuropathy
• Willingness to listen to music and voluntary participation
• Literacy (able to read and write)
• No visual or hearing impairments
• No cognitive deficits; fully oriented to time, place, and person
• Turkish-speaking
• No formal music education

Exclusion Criteria

• Diagnosis of diabetes or diabetic foot
• Use of analgesic medications prior to or during routine wound care
• Individuals younger than 18 or older than 65 years
• Patients with psychiatric disorders
• Individuals with intellectual disabilities
• Patients with severe anxiety levels (STAI-S score 60-79 indicating severe anxiety)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Gülay OYUR ÇELİK

Asst. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

İzmir Katip Çelebi Üniversitesi

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

0553

Identifier Type: -

Identifier Source: org_study_id